NCT01491100已完成不适用
Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,085
- 主要终点
- Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)
研究概览
简要总结
Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Relapsing Remitting Multiple Sclerosis (RRMS), and treated with Betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of Betaferon by the physician
- •EDSS 0 - 6
- •Written informed consent
排除标准
- •Patients who do not meet the local indication criteria for Betaferon treatment.
- •Contraindications listed in the local SmPCs have to be considered.
- •Patients with a history of severe head trauma.
- •Patients with alcohol and/or drug abuse.
- •Patients with mental retardation.
- •Patients with learning disability.
研究组 & 干预措施
Group 1
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)
时间窗: 24 months
Physical activity as measured by the Baecke questionnaire
时间窗: 24 months
次要结局
- Disability as measured by EDSS (Expanded Disability Status Scale)(24 months)
- Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)(24 months)
- Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)(24 months)
- Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)(24 months)
研究者
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